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Radioactive seeds zapped tumors from the inside — but trial stopped early

NCT ID NCT03886181

Disease control Sponsor: Alpha Tau Medical LTD. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested a device that places radioactive seeds directly into skin, mouth, or soft tissue tumors. The seeds release alpha radiation to kill cancer cells from within. Only 2 people took part before the trial was stopped, so we don't have enough information to know if it works or is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Diffusing Alpha Radiation Emitters Therapy (DaRT) device
What this could lead to
If it works, this could offer a new way to treat superficial tumors by delivering targeted radiation from inside the tumor.
What could go wrong
This very early trial was terminated after enrolling only 2 people, so we have very little data. The approach may not prove safe or effective in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2 people

The number who actually took part.

Started

Jul 2021

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia. * Subjects with a tumor size ≤ 5 centimeters in the longest diameter. * Subjects' age is over 18 years old. * Subjects' ECOG Performance Status Scale is \< 2. * Subjects' life expectancy is more than 6 months. * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test. * Subjects are able and willing to sign an informed consent form. Exclusion Criteria: * Subject has a tumor with a maximal diameter \> 5 centimeters. * Subjects' ECOG Performance Status Scale is \> 3. * Subject has a tumor of Keratoacanthoma histology. * Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc. * Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.

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Conditions

The condition(s) this trial relates to.

basal cell carcinoma Kaposi's sarcoma lip cancer malignant soft tissue neoplasm oral cavity neoplasm skin cancer skin neoplasm soft tissue neoplasm Soft Tissue Neoplasms squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck tongue cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mucosal neoplasm of oral cavity Skin cancer Soft tissue neoplasm

Contacts and locations

Locations

  • IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e Prevenzione

    Rome, Lazio, Italy

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